510(k) Report

Devices descending from K062444

5 later devices reach HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+1K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+1K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+2K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+2K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—